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The purpose of this trial is to evaluate the safety and efficacy of combination therapy of aliskiren/hydrochlorothiazide (HCTZ) 150/25 mg and 300/25 mg compared with HCTZ 25 mg in patients with hypertension who do not show response to HCTZ 25 mg over a 4-week period.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aliskiren/HCTZ | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Mean sitting diastolic blood pressure lowering effect at baseline, and week 8. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean sitting systolic blood pressure (msDBP) lowering from baseline to week 8 | ||
| Safety and tolerability | ||
| Proportion of patients achieving a blood pressure control target at week 8 |
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Inclusion Criteria:
Male or female outpatients 18 years old or older.
Patients with a diagnosis of hypertension defined as follows:
Patients who are eligible and consent to participate in the study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Pharmaceuticals | East Hanover | New Jersey | 07936 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19245300 | Result | Blumenstein M, Romaszko J, Calderon A, Andersen K, Ibram G, Liu Z, Zhang J. Antihypertensive efficacy and tolerability of aliskiren/hydrochlorothiazide (HCT) single-pill combinations in patients who are non-responsive to HCT 25 mg alone. Curr Med Res Opin. 2009 Apr;25(4):903-10. doi: 10.1185/03007990902804158. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D006337 | Heart Murmurs |
| D054160 | Systolic Murmurs |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Investigative Centers |
| Germany |